[Federal Register Volume 69, Number 137 (Monday, July 19, 2004)]
[Notices]
[Pages 42998-42999]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-16304]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004N-0062]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Color Additive
Certification Requests and Recordkeeping
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by August
18, 2004.
ADDRESSES: OMB is still experiencing significant delays in the regular
mail, including first class and express mail, and messenger deliveries
are not being accepted. To ensure that comments on the information
collection are received, OMB recommends that comments be faxed to the
Office of Information and Regulatory Affairs, OMB, Attn: Fumie Yokota,
Desk Officer for FDA, FAX: 202-395-6974.
FOR FURTHER INFORMATION CONTACT: Peggy Robbins, Office of Management
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-1223.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Color Additive Certification Requests and Recordkeeping--21 CFR Part 80
(OMB Control Number 0910-0216)--Extension
FDA has regulatory oversight for color additives used in foods,
drugs, cosmetics, and medical devices. Section 721(a) of the Federal
Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 379e(a)) provides
that a color additive shall be deemed to be unsafe unless it meets the
requirements of a listing regulation, including any requirement for
batch certification, and is used in accordance with the regulation. FDA
lists color additives that have been shown to be safe for their
intended uses in title 21 of the Code of Federal Regulations (CFR). FDA
requires batch certification for all color additives listed in 21 CFR
part 74 and for all color additives provisionally listed in 21 CFR part
82. Color additives listed in 21 CFR part 73 are exempted from
certification.
The requirements for color additive certification are described in
part 80 (21 CFR part 80). In the certification procedure, a
representative sample of a new batch of color additive, accompanied by
a ``request for certification'' that provides information about the
batch, must be submitted to FDA's Office of Cosmetics and Colors. FDA
personnel perform chemical and other analyses of the representative
sample and, providing the sample satisfies all certification
requirements, issue a certification lot number for the batch. FDA
charges a fee for certification based on the batch weight and requires
manufacturers to keep records of the batch pending and after
certification.
Under Sec. 80.21, a request for certification must include: Name
of color additive, manufacturer's batch number and weight in pounds,
name and address of manufacturer, storage conditions, statement of
use(s), certification fee, and signature of person requesting
certification. Under Sec. 80.22, a request for certification must
include a sample of the batch of color additive that is the subject of
the request. The sample must be labeled to show: Name of color
additive, manufacturer's batch number and quantity, and name and
address of person requesting certification. Under Sec. 80.39, the
person to whom a certificate is issued must keep complete records
showing the disposal of all the color additive covered by the
certificate. Such records are to be made available upon request to any
accredited representative of FDA until at least 2 years after disposal
of all of the color additive.
The purpose for collecting this information is to help FDA assure
that
[[Page 42999]]
only safe color additives will be used in foods, drugs, cosmetics, and
medical devices sold in the United States. The required information is
unique to the batch of color additive that is the subject of a request
for certification. The manufacturer's batch number is used for
temporarily identifying a batch of color additive until FDA issues a
certification lot number and for identifying a certified batch during
inspections. The manufacturer's batch number also aids in tracing the
disposal of a certified batch or a batch that has been refused
certification for noncompliance with the color additive regulations.
The manufacturer's batch weight is used for assessing the certification
fee. The batch weight also is used to account for the disposal of a
batch of certified or certification-rejected color additive. The batch
weight can be used in a recall to determine whether all unused color
additive in the batch has been recalled. The manufacturer's name and
address and the name and address of the person requesting certification
are used to contact the person responsible should a question arise
concerning compliance with the color additive regulations. Information
on storage conditions pending certification is used to evaluate whether
a batch of certified color additive is inadvertently or intentionally
altered in a manner that would make the sample submitted for
certification analysis unrepresentative of the batch. FDA checks
storage information during inspections. Information on intended uses
for a batch of color additive is used to assure that a batch of
certified color additive will be used in accordance with the
requirements of its listing regulation. The statement of the fee on a
certification request is used for accounting purposes so that a person
requesting certification can be notified promptly of any discrepancies.
In the Federal Register of February 26, 2004 (69 FR 8977), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
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Annual
21 CFR Section No. of Frequency per Total Annual Hours per Total Hours
Respondents Response Responses Response
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80.21 23 200 4,603 0.20 921
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80.22 23 200 4,603 0.05 230
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Total 0.25 1,151
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2.--Estimated Annual Recordkeeping Burden\1\
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Annual
21 CFR Section No. of Frequency of Total Annual Hours per Total Hours
Recordkeepers Recordkeeping Records Record
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80.39 23 200 4,603 0.25 1,151
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Total 1,151
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
The annual burden estimate for this information collection is 2,302
hours. The estimated reporting burden for this information collection
is 1,151 hours and the estimated recordkeeping burden for this
information collection is 1,151 hours. From fiscal years 2001 to 2003,
FDA processed an average of 4,603 responses (requests for certification
of batches of color additives) per year. There were 23 different
respondents, corresponding to an average of approximately 200 responses
from each respondent per year. Using information from industry
personnel, FDA estimates that an average of 0.25 hour per response is
required for reporting (preparing certification requests and
accompanying sample labels) and an average of 0.25 hour per response is
required for recordkeeping.
Dated: July 13, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-16304 Filed 7-16-04; 8:45 am]
BILLING CODE 4160-01-S